10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MR SPECTROSCOPY PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009
LH-75 PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
sam 2.0 Long Duration Ultrasound System
FDA 510(k)
FDA Class 2
·Physical Medicine
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 6, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·January 28, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
FDA Recall
Terminated
·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·December 2, 2014
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
FDA Recall
Terminated
·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·June 21, 2013